CN114869942B

CN114869942B - Traditional Chinese medicine composition for treating constipation and preparation method thereof

Info

Publication number: CN114869942B
Application number: CN202210440239.5A
Authority: CN
Inventors: 郭姣
Original assignee: Guangdong Pharmaceutical University
Current assignee: Guangdong Pharmaceutical University
Priority date: 2022-04-25
Filing date: 2022-04-25
Publication date: 2023-06-06
Anticipated expiration: 2042-04-25
Also published as: CN114869942A

Abstract

The invention discloses a traditional Chinese medicine composition for treating constipation and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following components in parts by weight: 8-20 parts of bighead atractylodes rhizome, 10-30 parts of magnolia officinalis, 10-40 parts of immature bitter orange, 20-50 parts of Chinese angelica, 5-10 parts of American ginseng, 15-40 parts of cistanche, 15-35 parts of fructus cannabis and 30-50 parts of astragalus membranaceus. Compared with the prior art, the composition has the effects of tonifying qi and nourishing yin, promoting qi circulation and relaxing bowel, and has remarkable treatment effect on chronic transmission type constipation.

Description

Traditional Chinese medicine composition for treating constipation and preparation method thereof

Technical Field

The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating constipation and a preparation method thereof.

Background

Constipation is a gastrointestinal motility disorder, which causes trouble to the daily life of the patient, and long-term constipation may also cause complications such as perianal diseases, megacolon, colonic diverticulum and the like, and seriously affects the physical and mental health of the patient. The modern medicine mainly treats chronic transmission constipation through oral medicines such as gastrointestinal motility promoting medicines, cathartic agents and the like, but the medicines are easy to cause dependence on human bodies and cause adverse reactions after long-term use. The operation treatment has strict indication, and has the defects of large damage, inaccurate curative effect, more complications, slow postoperative recovery and the like, so the clinical application limitation is larger.

The traditional Chinese medicine has unique advantages in treating constipation, for example, CN103285218A discloses a traditional Chinese medicine compound for treating constipation caused by spleen-kidney yang deficiency, which is prepared from the following raw materials in parts by weight: 20 to 40 parts of cistanche salsa, 20 to 40 parts of epimedium herb, 6 to 12 parts of cinnamon, 10 to 20 parts of ginger processed pinellia tuber, 10 to 20 parts of magnolia officinalis, 20 to 40 parts of allium macrostemon, 20 to 40 parts of kudzuvine root, 20 to 40 parts of poria cocos and 30 to 60 parts of Chinese angelica. The invention combines the formula according to the theory of traditional Chinese medicine and the pathogenesis of spleen-kidney yang deficiency type constipation, and shows good efficacy of treating the spleen-kidney yang deficiency type constipation. CN108785517a discloses a traditional Chinese medicine composition for treating constipation and a preparation method thereof, wherein the prescription of the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 18-20 parts of engelhardtia, 13-15 parts of rhizoma atractylodis, 13-15 parts of bighead atractylodes rhizome, 4-5 parts of dried orange peel, 9-10 parts of dried rehmannia root, 8-10 parts of dwarf lilyturf tuber, 4-5 parts of ginseng, 7-10 parts of poria cocos, 8-10 parts of grifola, 8-10 parts of oriental waterplantain rhizome, 18-20 parts of Chinese angelica, 4-5 parts of amur corktree bark, 3-5 parts of coptis root, 4-5 parts of Chinese thorowax root, 2-3 parts of cimicifuga rhizome, 1-3 parts of Chinese magnoliavine fruit, 3-5 parts of liquorice and 0.1-0.3 part of borneol. CN104740437a discloses a traditional Chinese medicine composition for treating constipation and a preparation method thereof, wherein the prescription composition comprises astragalus membranaceus, american ginseng, rehmannia root, prepared rehmannia root, bighead atractylodes rhizome, cistanche salsa, mulberry, bran-fried immature bitter orange, mangnolia officinalis, bunge cherry seed, fructus cannabis, bitter apricot seed, black sesame, angelica sinensis, coastal glehnia root, medlar, dwarf lilyturf tuber, cassia twig, morinda officinalis, betel nut, fried chicken's gizzard-skin, dried orange peel, fried malt and scorched hawthorn fruit, the medicines are combined, and the medicines are decocted together to be dissolved together, so that the medicine property of the medicines can be used for removing the effects of tonifying qi, nourishing blood and relaxing bowel, and the traditional Chinese medicine composition can be used for treating intractable constipation of old patients caused by deficiency of both qi and blood.

Slow-transit constipation is a type of constipation characterized by reduced colonic motility and prolonged colonic transit time. The course of the disease is unstable, and the abuse of the laxative in the modern society causes colon damage, intestinal canal expansion and treatment of patients to be more difficult. The traditional Chinese medicine has unique knowledge for treating constipation. In ancient books, constipation symptoms were summarized earlier, for example, in "Su Wen-Jue Lun" in Taiyin Jue Ji, if the abdomen is full and the Bin is distended, then adverse effects occur. The Shang Han theory and pulse-distinguishing method suggests that the pulse is superficial and rapid, and can not eat the stool, which is true … …, the pulse is deep and slow, can not eat, the body weight and the stool are hard. How to fully exert the synergistic effect among the traditional Chinese medicines, simplify the formula, and provide a safe and effective traditional Chinese medicine composition for treating constipation and a preparation method thereof have important significance.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating constipation and a preparation method thereof, wherein the composition has simple components and good safety, can fully exert the synergistic effect among medicines, has the effects of tonifying qi and nourishing yin, promoting qi circulation and relaxing bowel, and has remarkable treatment effect on slow-transmission constipation.

In order to achieve the above object, the present invention provides the following technical solutions:

a traditional Chinese medicine composition for treating constipation comprises the following components in parts by weight: : 8-20 parts of bighead atractylodes rhizome, 10-30 parts of magnolia officinalis, 10-40 parts of immature bitter orange, 20-50 parts of Chinese angelica, 5-10 parts of American ginseng, 15-40 parts of cistanche, 15-35 parts of fructus cannabis and 30-50 parts of astragalus membranaceus.

Preferably, the traditional Chinese medicine composition for treating constipation comprises the following components in parts by weight: : 8-16 parts of bighead atractylodes rhizome, 10-25 parts of magnolia officinalis, 10-35 parts of immature bitter orange, 20-44 parts of Chinese angelica, 5-9 parts of American ginseng, 15-35 parts of cistanche, 15-32 parts of fructus cannabis and 30-45 parts of astragalus membranaceus.

Most preferably, the traditional Chinese medicine composition for treating constipation comprises the following components in parts by weight: : 12 parts of bighead atractylodes rhizome, 18 parts of magnolia officinalis, 20 parts of immature bitter orange, 30 parts of Chinese angelica, 8 parts of American ginseng, 30 parts of cistanche, 25 parts of fructus cannabis and 40 parts of astragalus mongholicus.

The invention also provides a traditional Chinese medicine extract for treating constipation, which is obtained by extracting the traditional Chinese medicine composition.

The invention also provides a method for preparing the traditional Chinese medicine composition, and the preparation method is an extraction method.

Preferably, the extraction is at least one of water decoction, immersion, percolation, modified gelatin, reflux, solvent extraction, steam distillation, sublimation, supercritical fluid extraction, membrane separation, superfine pulverizing, flocculation separation, semi-bionic extraction, ultrasonic extraction, cyclone extraction, pressurized countercurrent extraction, enzyme, macroporous resin adsorption, ultrafiltration and molecular distillation.

The invention also provides application of the traditional Chinese medicine composition for treating constipation in preparing a medicine for treating constipation.

The invention also provides application of the traditional Chinese medicine extract for treating constipation in preparing a medicine for treating constipation.

Preferably, the constipation is slow-transit constipation.

The invention also provides a medicine for treating constipation, which comprises the traditional Chinese medicine composition or the traditional Chinese medicine extract.

Preferably, the dosage form of the medicine is tablets, capsules, granules, dripping pills, soft capsules or oral liquid.

The beneficial effects of the invention are as follows:

the traditional Chinese medicine composition for treating constipation disclosed by the invention is prepared from eight components including bighead atractylodes rhizome, magnolia officinalis, immature bitter orange, chinese angelica, american ginseng, cistanche, fructus cannabis and astragalus mongholicus, can fully exert the synergistic effect of all the raw materials, has the effects of tonifying qi and nourishing yin, and promoting qi circulation and relaxing bowel, and has a remarkable treatment effect on slow-transmission constipation.

Drawings

FIG. 1 shows the results of HE staining of colon tissue of mice.

Fig. 2 shows the small intestine thrust rate.

Fig. 3 is a 6 hour fecal pellet count in units of: and (5) granulating.

Fig. 4 is total fecal weight in 6 hours, in units of: g.

fig. 5 is a first granule of black bowel time in units of: and (5) min.

Wherein, P <0.05 compared to ctrl group; # indicates that P <0.05 compared to the model group.

Detailed Description

Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention.

Before the embodiments of the invention are explained in further detail, it is to be understood that the invention is not limited in its scope to the particular embodiments described below; it is also to be understood that the terminology used in the examples of the invention is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the invention.

Where numerical ranges are provided in the examples, it is understood that unless otherwise stated herein, both endpoints of each numerical range and any number between the two endpoints are significant both in the numerical range. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

The raw materials adopted by the invention are all common commercial products unless specified. Wherein the Atractylodis rhizoma can be bran-parched Atractylodis rhizoma, cortex Magnolia officinalis can be rhizoma Zingiberis recens cortex Magnolia officinalis, fructus Aurantii Immaturus can be processed fructus Aurantii Immaturus, and Cistanchis herba can be herba cistanches.

Intestine moistening recipe-example 1

A traditional Chinese medicine composition for treating constipation comprises the following components in parts by weight: 8 parts of bighead atractylodes rhizome, 10 parts of magnolia officinalis, 10 parts of immature bitter orange, 20 parts of Chinese angelica, 5 parts of American ginseng, 15 parts of cistanche, 15 parts of fructus cannabis and 30 parts of astragalus mongholicus.

The preparation method of the traditional Chinese medicine composition comprises the following steps:

(1) Pulverizing Atractylodis rhizoma, cortex Magnolia officinalis, fructus Aurantii Immaturus, radix Angelicae sinensis, radix Panacis Quinquefolii, cistanchis herba, fructus Cannabis and radix astragali, mixing, extracting with water for 2 hr for three times, mixing the filtrates, adding cyclodextrin 0.3% of the total mass of the filtrate, concentrating under reduced pressure, and drying to obtain the final product;

(2) Pulverizing the traditional Chinese medicine extract obtained in the step (1), and sieving with a 60-mesh sieve to obtain the traditional Chinese medicine composition for treating constipation.

Intestine moistening recipe-example 2

A traditional Chinese medicine composition for treating constipation consists of the following components in parts by weight: 20 parts of bighead atractylodes rhizome, 30 parts of magnolia officinalis, 40 parts of immature bitter orange, 50 parts of Chinese angelica, 10 parts of American ginseng, 40 parts of cistanche, 35 parts of fructus cannabis and 50 parts of astragalus mongholicus.

The preparation method is the same as in example 1.

Intestine moistening recipe-example 3

A traditional Chinese medicine composition for treating constipation consists of the following components in parts by weight: 12 parts of bighead atractylodes rhizome, 18 parts of magnolia officinalis, 20 parts of immature bitter orange, 30 parts of Chinese angelica, 8 parts of American ginseng, 30 parts of cistanche, 25 parts of fructus cannabis and 40 parts of astragalus mongholicus.

The preparation method is the same as in example 1.

Intestine moistening recipe-comparative example 1

A traditional Chinese medicine composition for treating constipation consists of the following components in parts by weight: 25 parts of bighead atractylodes rhizome, 18 parts of magnolia officinalis, 8 parts of immature bitter orange, 60 parts of Chinese angelica, 4 parts of American ginseng, 30 parts of cistanche, 40 parts of fructus cannabis and 25 parts of astragalus membranaceus.

The preparation method is the same as in example 1.

Intestine moistening recipe-comparative example 2

A traditional Chinese medicine composition for treating constipation consists of the following components in parts by weight: 12 parts of bighead atractylodes rhizome, 18 parts of magnolia officinalis, 20 parts of dwarf lilyturf tuber, 30 parts of Chinese angelica, 8 parts of American ginseng, 30 parts of cistanche, 25 parts of rehmannia root, 10 parts of cassia twig and 40 parts of astragalus root.

The preparation method is the same as in example 1.

In order to better embody the advantages of the invention, animal experiments and results of the traditional Chinese medicine composition (intestine moistening formula) for treating constipation provided by the invention are given below.

Example 4

1. Experimental materials

1.1 laboratory animals

Adult male mice are selected and weighing 18-22g.

1.2 Main equipment, instruments and consumables

Surgical scissors (Ruiwod), ophthalmic forceps (Ruiwod), ruler (Yongguang 00722098), syringe (China double pigeon group Jimmy Biotechnology Co., ltd.), balance (Shanghai Anting electronic instruments factory 00000378), activated carbon powder (Jingchuan carbon treasure), gum arabic (Western A reagent ISO 9001), loperamide (Yimengting 81449461327522386423).

2. Principle of experiment

2.1 small intestine movement experiments

The molding drug loperamide is administrated by oral gastric lavage, a mouse small intestine peristalsis inhibition model is established, and the ink propelling rate of the small intestine in a certain time is calculated to judge the gastrointestinal peristalsis function of the model mouse.

2.2 determination of faeces discharge time, faeces particle count and faeces weight

The model drug loperamide is administrated by oral gastric lavage, a constipation model of the mice is built, and the defecation time of first grain defecation black stool of the mice, the defecation grain number within 6 hours and the defecation weight of the mice are measured to reflect the defecation condition of the model mice.

3. Experimental method

3.1 small intestine movement experiment

3.1.1 random grouping

All mice were randomly divided into a blank control group (Ctrl), a Model group (Model), and an intestine-moistening prescription group according to a random number table method according to body weight: examples 1-3 and comparative examples 1-2, 11-12 per group.

3.1.2 pharmaceutical intervention

After 7 days of administration of the test sample, each group of mice fasted without water for 16 hours. Loperamide (4 mg/kg BW) was given to the model control and the enteral formula groups by lavage, and distilled water was given to the blank control. The recommended dose of the human body is 10 times (5 g/kg), and no positive control group exists. Distilled water was given to the negative control group and the model control group by the same route. The enteral formula was administered for 7 days.

Preparing ink: accurately weighing 100g of gum arabic, adding 800mL of water, boiling until the solution is transparent, weighing 50g of activated carbon (powder) and adding into the solution, boiling for three times, cooling the solution, adding water to 1000mL, keeping the volume at 4 ℃ in a refrigerator, and shaking uniformly before use.

Preparation of loperamide solution: the loperamide dose was 4mg/kg BW. According to the practical dosage of loperamide, the loperamide is prepared according to the concentration required by experiments, and can be heated for use after the solute is completely dissolved and fully shaken.

3.2 determination of faeces discharge time, faeces particle count and faeces weight

3.2.1 random grouping

All mice were randomly divided into a blank control group (Ctrl), a Model group (Model), and an intestine-moistening prescription group according to a random number table method according to body weight: example 1, example 2, example 3, comparative example 1, comparative example 2, 6-8 per group.

3.2.2 pharmaceutical intervention

After 7 days of the enteral formula, each group of mice was fasted without water for 16 hours. The negative control group was given distilled water, the model control group and the intestine-moistening formula group were given loperamide (7 mg/kg BW) by lavage. The recommended dose of the human body is 10 times (5 g/kg), and no positive control group exists. Distilled water was given to the negative control group and the model control group by the same route.

Preparation of loperamide solution: the loperamide dose was 7mg/kg BW. According to the practical dosage of loperamide, the loperamide is prepared according to the concentration required by experiments, and can be heated for use after the solute is completely dissolved and fully shaken.

3.3 notes

3.3.1 in the experiment the suspension of the compound diphenoxylate should be constantly oscillated to keep its concentration uniform. The loperamide solution may crystallize when stored at 4 deg.c and may be dissolved after leaving room temperature for some time or after heating.

3.3.2 adding carbon powder after the Arabic gum is heated and transparent during the preparation of the ink.

3.3.3 the feces from the mice before the first dark feces were discharged should be removed.

4. Index determination method

4.1 small intestine movement experiments

After 0.5 hours from loperamide administration, the intestine-moistening formulation was given ink (5% active carbon powder, 10% gum arabic) with the corresponding test sample, respectively, and the negative and model control groups were given ink lavage.

Immediately after 25 minutes, the animals were sacrificed by cervical vertebra removal, the celiac separation mesentery was opened, the upper end from the pylorus, the lower end to the ileocecum were cut off, the intestinal canal was placed on a tray, the small intestine was gently pulled into a straight line, the length of the intestinal canal was measured as the "total length of the small intestine", and the front edge from the pylorus to the ink was the "push length of the ink".

The ink push rate was calculated as follows: ink advance (%) =ink advance length (cm) ×100%/total small intestine length (cm).

4.2 determination of faeces discharge time, faeces particle count and faeces weight

After 7 days in the intestine-moistening formula, each group of mice was fasted without water for 16 hours. After loperamide is given for 0.5 hour, mice in the negative control group and the model control group are filled with ink, the ink containing the sample is given to the intestine-moistening prescription group, and animals are fed in a single cage and normally drink water for feeding. From the ink filling, the black stool discharge time of the first grains of each animal, the number of black stool discharge grains in 6 hours and the weight are recorded.

5. Data processing and statistical analysis

5.1 small intestine movement experiments

The ink push rate needs to be subjected to data conversion,

wherein P is the ink push rate and is expressed by decimal. In performing analysis of variance, analysis of variance is requiredThe procedure firstly carries out variance alignment test, calculates F value and F value<F0.05, conclusion: the difference between the average numbers of the groups is not significant; f value is more than or equal to F0.05, P is less than or equal to 0.05, and statistics is carried out by a pairwise comparison method of average numbers between a plurality of experimental groups and a control group; proper variable conversion is carried out on the data with non-normal or variance, and statistics is carried out on the converted data after the normal or variance alignment requirement is met; if the normal or variance alignment purpose is not achieved after the variable conversion, the rank sum test is used for statistics.

On the premise that the model is established, when the ink propelling rate of the mice in the test sample group is obviously higher than that of the mice in the model control group, the test result can be judged to be positive.

5.2 determination of faeces discharge time, faeces particle count and faeces weight

The data can be analyzed by variance, the variance alignment is firstly checked according to the program of the variance analysis, the F value is calculated, the F value is less than F0.05, and the conclusion is that: the difference between the average numbers of the groups is not significant; f value is more than or equal to F0.05, P is less than or equal to 0.05, and statistics is carried out by a pairwise comparison method of average numbers between a plurality of experimental groups and a control group; proper variable conversion is carried out on the data with non-normal or variance, and statistics is carried out on the converted data after the normal or variance alignment requirement is met; if the normal or variance alignment purpose is not achieved after the variable conversion, the rank sum test is used for statistics.

On the premise that the constipation model of the small intestine is established, the first grain of the mice in the test sample group has obviously shorter defecation time than the model control group, and the positive result of the index can be judged.

The number of the black discharge excrement grains is obviously higher than that of a model control group within 6 hours, and the positive result of the index can be judged.

The weight of the black stool discharged within 6 hours is obviously higher than that of a model control group, and the positive result of the index can be judged.

6. Experimental results

6.1 morphological structural changes in the small intestine

Results of HE staining of colon tissue of mice (fig. 1) showed that the model group had flat lumen surface, damaged glands, thinning mucous membrane, and goblet cell reduction. However, these lesions can be significantly alleviated by taking the bowel-lubricating formulation of examples 1-3, which findings indicate that the bowel-lubricating formulation helps to restore the colon abnormalities in the loperamide-induced constipation mice.

6.2 small intestine movement experiments

According to the rule, for the small intestine movement experiment, on the premise that the model is established, when the ink propelling rate of the mice in the test sample group is obviously higher than that of the mice in the model control group, the positive result of the experiment can be judged.

As shown in fig. 2, the constipation model was successful in mice 0.5 hour after loperamide administration, and the small intestine propulsion rate of constipation mice significantly increased (P < 0.05) after treatment of examples 1-3 with the enteral formula of intragastric administration.

6.3 determination of defecation time, fecal particle number and fecal weight

According to the rule, on the premise that the small intestine constipation model is established, the first grain of the mice in the test sample group has a significantly shorter defecation time than the model control group for the measurement of defecation time, fecal grain number and fecal weight, and the positive result of the index can be judged. The number of the black discharge excrement grains is obviously higher than that of a model control group within 6 hours, and the positive result of the index can be judged. The weight of the black stool discharged within 6 hours is obviously higher than that of a model control group, and the positive result of the index can be judged.

As shown in FIG. 3, the number of black bowel movements discharged in examples 1-3,6 hours of the intestine-moistening formula group is obviously higher than that of the model control group (P < 0.05); bowel-lubricating formula group examples 1-3, total stool weight was significantly higher than model control group (P < 0.05) over 6 hours, as shown in fig. 4; meanwhile, in the examples 1-3 of the intestine-moistening prescription, the first granule of the urine and feces are also obviously shorter than that of the model control group (P < 0.05), as shown in figure 5.

In conclusion, the loperamide-induced slow-transmission constipation mice model is successful, and the intestinal propulsion rate of the constipation mice can be remarkably increased after the stomach irrigation treatment of the bowel-lubricating prescription examples 1-3, the total weight of feces for 6 hours is increased, the number of the feces grains is increased, and the first black feces discharge is accelerated. The invention shows that the intestine smoothing prescription provided by the invention can obviously accelerate the intestinal peristalsis of the mice with chronic transmission constipation induced by loperamide.

The foregoing detailed description is directed to one of the possible embodiments of the present invention, which is not intended to limit the scope of the invention, but is to be accorded the full scope of all such equivalents and modifications so as not to depart from the scope of the invention.

Claims

1. The traditional Chinese medicine composition for treating constipation is characterized by comprising the following components in parts by weight: 8-16 parts of bighead atractylodes rhizome, 10-25 parts of magnolia officinalis, 10-35 parts of immature bitter orange, 20-44 parts of Chinese angelica, 5-9 parts of American ginseng, 15-35 parts of cistanche, 15-32 parts of fructus cannabis and 30-45 parts of astragalus membranaceus.

2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following components in parts by weight: 12 parts of bighead atractylodes rhizome, 18 parts of magnolia officinalis, 20 parts of immature bitter orange, 30 parts of Chinese angelica, 8 parts of American ginseng, 30 parts of cistanche, 25 parts of fructus cannabis and 40 parts of astragalus mongholicus.

3. A traditional Chinese medicine extract for treating constipation, which is characterized by being extracted from the traditional Chinese medicine composition according to any one of claims 1-2.

4. Use of the traditional Chinese medicine composition according to any one of claims 1-2 for preparing a medicament for treating constipation.

5. Use of the extract of chinese medicine according to claim 3 for preparing a medicament for treating constipation.

6. The use of claim 5, wherein the constipation is slow-transit constipation.

7. A medicament for treating constipation, characterized by comprising the Chinese medicinal composition for treating constipation according to any one of the above claims 1-2 or the Chinese medicinal extract according to claim 3.

8. The medicament according to claim 7, wherein the medicament is in the form of a tablet, capsule, granule, dripping pill or oral liquid.